This is a fully remote position, open to applicants in New Jersey, +2 more states.

📋 Description

• Direct model-informed drug development strategies that support therapeutic areas including antibodies, siRNA, and gene therapies.

• Guide dose selection, trial design, and regulatory strategy from the early stages of development through to submission.

• Make significant contributions in Pharmacometrics for research and development initiatives.

• Assist in the strategic development of programs and convey complex Pharmacometrics strategies and outcomes to development teams.

• Design, execute, or supervise PMx analysis plans.

• Utilize standardized or advanced scientific methods to perform PK, PD, and other quantitative analyses.

• Prepare and deliver precise nonclinical or clinical study reports and regulatory submission documents in a timely manner.

⛳️ Requirements

• PhD in Quantitative Pharmacology, Pharmacometrics, Engineering, or a related discipline with 7+ years of post-doctoral or industry experience; or MS with 9+ years of pertinent experience.

• Proven expertise in population PK/PD, exposure-response, or mechanistic modeling (systems biology or QSP) utilizing tools such as NONMEM, Monolix, Simulx, MATLAB/Simbiology, and R.

• Established track record of providing analyses that support regulatory submissions and engaging directly with agencies (e.g., FDA, EMA, PMDA).

• Practical experience with a wide array of quantitative and computational tools.

• Strong publication record.

• Outstanding communication and interpersonal skills, with the capability to influence and collaborate effectively across both technical and non-technical teams.